To determine safety of oocyte vitrification.
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the number of congenital abnormalities in babies born after
oocyte vitrification (%).
Secondary outcome
Secondary outcomes are the number of oocytes retrieved and vitrified per woman
started, the number of women requesting the use of their vitrified oocytes (%),
the number of oocytes surviving the freeze-thaw process (%), the fertilisation
rate (%), the percentage of top quality embryos (%), number and type of
pregnancy outcome (biochemical-, clinical-, ongoing-, and multiple pregnancy
rate (%)) after transfer of freeze-thawed and fertilized oocytes, the live
birth rate in women undergoing oocyte vitrification (%), the live birth rate
per thaw cycle (%). Also, the number of women desiring children (%), live birth
rate after natural conception in the group under study (%), women intending to
become pregnant but failed (%), the number of congenital abnormalities after
natural conception (%), and the number and type of pregnancy outcome
(biochemical-, clinical-, ongoing-, multiple pregnancy rate (%) after natural
conception will be investigated.
Background summary
The aim of the study is to determine the safety of oocyte vitrification, by
means of an observational cohort study. The children born after oocyte
vitrification will be followed.
Women of reproductive age at risk of ovarian failure, defined as loss of
ovarian function might benefit from oocyte
vitrification to increase chances of future motherhood. Oocyte vitrification,
or ultra rapid egg freezing is a relatively new
technology with promising initial results. Worldwide over 900 babies have been
born after egg freezing, of which 392 after
oocyte vitrification. In these babies, no apparent increase in congenital
anomalies was found. We aim to establish safety
and efficacy of oocyte vitrification by performing a large observational cohort
study with follow up of women and children.
Study objective
To determine safety of oocyte vitrification.
Study design
Observational cohort study.
Study burden and risks
Although no increased risk is of congenital abnormalities is known in children
born after oocyte vitrification hitherto, a larger amount of children need to
be studied.
The burden of participation equals the burden of a standard IVF/ICSI cycle,
i.e. a 3-week period with controlled ovarian hormonal stimulation, ultrasound
monitoring (4-5 times), endocrine monitoring (4-5 times) and transvaginal
follicle aspiration. The risks to the women are limited to the risks associated
with the IVF/ICSI procedure such as ovarian hyperstimulation syndrome and
infection.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Women until their 40th birthday who are at risk of ovarian failure due to iatrogenic gonadotoxic treatment.
2. Women until their 40th birthday who are at risk of premature ovarian failure and women between the ages of 30th and 40th birthday who are at risk of ovarian failure due to increasing age.
3. Women until their 43rd birthday undergoing an IVF/ICSI cycle during which no spermatozoa can be obtained at the time of follicle aspiration.
Exclusion criteria
1. Women with borderline or invasive ovarian cancer.
2. Women with contraindications for IVF treatment such as cardiovascular-pulmonary disease, severe diabetes, bleeding disorders, immunodeficiency, morbid obesity, and premature ovarian failure.
3. Women with severe psychopathology, severe anxiety and inability to cope.
4. Women who reach, at the time they request thawing of their oocyte, the maximum age at which embryo transfer is accepted by Dutch guidelines (currently from their 45th birthday).
5. Not able or willing to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33893.000.10 |